VALIDATION PROTOCOL

FOR
DUST EXTRACTOR MACHINE
GMP MODEL
Purchase Order No.: HPP/170291 DATED 11-03-04

Cip Machineries Pvt. Ltd.

Registered Office :
10,11 Umiya Estate,
Nr.Bharat Party Plot, N.H.No.8,
Amraiwadi, Ahmedabad 380 026.
Gujarat, INDIA.
Phone: 91-79-2287 54 10
91-79-2289 25 30
91-79-2297 04 06-7-8
TeleFax: 91-79-2289 14 10

Works :
Plot No.1903, Phase IV,
Opp. Maradia Steel Unit-3,
G.I.D.C., Vatva,
Ahmedabad 380 026.
Gujarat, INDIA.
Phone: 91-79-2583 59 08
91-79-2583 53 41-2-3
TeleFax: 91-79-2583 58 53

E-Mail : cipmachad1@sancharnet.in

sales@cipmach.com
Visit us on Internet at :

www.cipmach.com / www.roll-compactor.com

OUR VISION : TO ACHIEVE LEADERSHIP THROUGH QUALITY

Confidential
VALIDATION PROTOCOL FOR
DUST EXTRACTOR MACHINE

Table of Content
Section
No.
1.0
2.0
3.0
4.0
5.0
6.0
7.0

Description

7.1
7.2
7.3
7.4
7.5
7.6
8.0
9.0
10.0
11.0
12.0
13.0
14.0
15.0
16.0

Title
Objective
Scope
Re qualification criteria
Over view of equipments / description
Definition
Responsibilities
Quality Engineering
Quality Assurance
Quality Control
Purchase
Production
Engineering
Indented use of instrument
Acceptance Criteria
Reference
Installation Qualification
Standard Operating Procedure
Operation Qualification
Performance Qualification
Preventive Maintenance Schedule
Final Conduction and recommendations

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VALIDATION PROTOCOL FOR
DUST EXTRACTOR MACHINE

PAGE 3 of 13

1.0 Title : Protocol for qualification of Dust Extractor Machine.

2.0 Objective : The objective of this protocol is to define the installation, operation and
performance Qualification requirement and qualifying criteria recommended from its Design
specification.

3.0 Scope : This qualification protocol is applicable to the Dust Extractor Machine.
4.0 Re qualification Criteria
Re qualification will be recommended in the following cases:
a. When there is change in location of the equipment.
b. When there is major modification in the equipment.
c. When there is major breakdown, which have direct impact on performance of the
equipment.
Re qualification shall be recommended by Quality Engineering.

5.0 Overview of Equipment / Description:

The equipment is a self-contained unit for collection of dust from the tableting etc. machine.

6.0 Definition
Qualification: The process of ensuring that equipment is appropriate for its intended use. It consists
of the following:
a. Installation Qualification: A documents verification of the installation in the selected user
environment to comply with the approved design, the manufacturers recommendations and or
user requirements.
b. Operation Qualification: A documents demonstration that facilities and operation work to
functional design specifications.
c. Performance Qualification: A documents verification of the performance in the selected user
environment to comply with the approved design, the manufacturers recommendations and or
user requirements.

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VALIDATION PROTOCOL FOR
DUST EXTRACTOR MACHINE

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7.0 Responsibilities:
7.1 Quality Engineering:
- Preparation, approval and implementation of the protocol.
- On going compliance of the system.
- Organizing the activities related to qualification.
- Co ordination with production, engineering purchase department.
- Qualification reports preparation.
7.2 Quality Assurance:
- Review, monitoring and approval of the protocol.
- On going compliance of the quality system.
7.3 Quality Control:
- Analysis of samples if any.
- Recording the QC raw data.
7.4 Purchase:
- Organization Preparation, approval and implementation of the protocol.
- Purchase order preparation.
- Co-ordination with vendor for related activities.
7.5 Production:
- Organizing the activities related to qualification in production area.
- SOP preparation for operation.
- Routine calibration and maintenance implementation.
- Report review and training of users.
7.6 Engineering:
- Providing the design specification.
- Inspection at vendor site.
- Utilities arrangement for equipment.
- Organize the calibration of parts of equipments & instruments as a whole.
- Organizing the activities related to qualification.

8.0 Intended use of the Equipment: The Dust Extractor Machine shall be used for suction of dust.
9.0 Acceptance Criteria:
a. Equipment shall be supplied and installed as per pre determined specification Purchase Order.
b. Material of construction and finish surface of equipment shall be as per pre determined
specification.
c. All Utilities connected with the equipment shall be as per requirement.
d. All components of the equipment shall work or function as defined.
e. Equipment shall perform for its intended use as specified.

10.0

Reference:

a. Technical specification / Operation Manual

b. GA drawing / Exploded drawing
c. Purchase order copy

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VALIDATION PROTOCOL FOR
DUST EXTRACTOR MACHINE

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d. FAT and SAT report recommendation.

11.0

Installation Qualification:

11.1 Equipment Details:

Equipment Name
Dust Extractor
Machine

Equipment Type

Designed By

Location (Floor)
Location (Plant)
Date of Installation

11.2 Major Components & Material of Construction:

Sr.
Description
Specification
No.
01
Chamber
SS 316
02
Impeller
CIP MAKE
03
Cotton Bag
CIP MAKE
04
Motor
1 Hp
05
Wheel
Pu
11.3 Utility Details:
Sr.
Utilities recommended by
No.
the vendor

Specification

01
02
03
04
05
06

1 Hp, 3 phase
NA
NA
NA
NA
NA

Electrical
Chilled water
Cooling water
Hot water
Compressed air
Steam pressure

11.4 Installation Checks:

Sr.
Test
No.
01
Position as per GA drawing
02

Electrical connection

04

Direction of Motor

05

Earthing

Actual

Remarks

Utility connected
with the
equipment

Remarks

Test Procedure
Ensure that position of
equipment is as per the
GA drawing
Check 3 phase supply to
starter through a proper
isolator with suitable
backup MCBs.
Check direction of motor
depending upon suction
Check the earthing of
machine

Observation

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VALIDATION PROTOCOL FOR
DUST EXTRACTOR MACHINE
Installation done by:
11.5

PAGE 6 of 13
Verified by:

FINAL REPORT

Summary:
The equipment shall be procured as per specification. Installation is carried out as per
manufacturers recommendations and user applicability. Supporting utilities will be connected.
Analysis / Evaluation:
The machine shall be installed at the location. Supporting utilities shall be connected and Used for
Functioning properly. Standard operating procedure shall be identified and listed. History card
shall be prepared for the equipment. The user shall verify all relevant critical document and
drawing.

Reviewed & Inspected by: ___________________

Date :

Approval:
Area Representative

Production
Engineering Services
Quality Engineering
Quality Assurance

Signature

Date

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VALIDATION PROTOCOL FOR
DUST EXTRACTOR MACHINE

12.0

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Standard Operating Procedure:

Draft SOP of the equipment shall be available

SOP No.

Title

Location

Effective
Date

Revision
No.

Remarks

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VALIDATION PROTOCOL FOR
DUST EXTRACTOR MACHINE

13.0

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Operational Qualification:

13.1 Procedure: The equipment (Dust Extractor Machine) shall be checked for the following
parameters:
13.2 Operational Checks:
Sr.
No.
01

Activity

Specification

On / Off Test

03
04

Start Machine with proper

suction direction
Test for vibration

Machine should be
ON and OFF with
operating buttons
Smooth running

05

Test for noise

06

Stopping of the Machine

Observation

Remarks

No abnormal
vibration
No abnormal Noise
should be there.
Machine should
STOP

13.3 Safety Features:

Sr.
No.
01
02

Safety features
provided with
the equipment
Proper earthing to
the machine
Safety interlocks
if any

Method of
Verification

Target

Ensure that there is

no loose earthing
Should work as
designed

Complete
earthing
No deviation

Actual

Remarks

13.4 Training:
Following operating / maintenance personnel were trained by the vendor and authorized to operate
or carryout routine maintenance of the equipment.
Name

Designation

Date of Training

Trained by

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VALIDATION PROTOCOL FOR
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13.5 FINAL REPORT

Summary
The operation of the equipment DUST EXTRACTOR MACHINE is carried out as per standard
operating procedure.
The equipment performs within the assigned limits when operated as per approved standard
operating procedure.
Operating parameters that have a significant impact on the equipment ability to operate and
achieve the process are satisfactory and confirms to the acceptance criteria.
Equipment: DUST EXTRACTOR MACHINE
Location
Purpose

:
: Use for suction of the dust.

Frequency of Validation: Validation due on

component of the machine.

or the event of any change in critical

"THE EQUIPMENT "DUST EXTRACTOR MACHINE VALIDATED AND RELEASED

FOR USE.

Approval:
Area Representative

Production
Engineering Services
Quality Engineering
Quality Assurance

Signature

Date

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VALIDATION PROTOCOL FOR
DUST EXTRACTOR MACHINE

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14.0 PERFORMANCE QUALIFICATION

14.1

EQUIPMENT VALIDATION

The simulation of the process was carried out by connection with the specific machine.
Simulation of the process consist of the following:
Sr.No. Activity
01

Proper assembly of cotton bags

02

Position of chamber

03

Powder suction

Functional Acceptance
Criteria
As per the details given with
the operating manual
It should be properly fixed
with machine and fixed with
knobs.
It should be from the specific
machine with this machine to
be attached.

Status / Observation

14.2 PERFORMANCE QUALIFICAION EVALUATION:

NAME OF TABLET:
PERFORMANCE CRITERIA - BEFORE CONNECTING THIS MACHINE:
1. APPERANCE :
2. ANAYALSIS
PERFORMANCE CRITERIA - AFTER CONNECTING THIS MACHINE:
1

APPERANCE
ANAYALSIS
14.3

DATA EVALUATION AND CONCLUSION:

Based on the quality control results generated by simulating the process and its review, it
said that machine performs satisfactory and confirming to the acceptance criteria.

Inspected by: _____________________Date :

can be

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VALIDATION PROTOCOL FOR
DUST EXTRACTOR MACHINE

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14.4 FINAL REPORT

Summary
The performance of the equipment DUST EXTRACTOR MACHINE was carried out as
standard operating procedure.

per

The equipment performs within the assigned limits when operated as per approved standard
operating procedure.
Performance parameters that have a significant impact on the equipment ability to operate and
achieve the process are satisfactory and confirms to the acceptance criteria.
Equipment: DUST EXTRACTOR MACHINE
Location
Purpose

:
: Use for suction of the dust.

"THE EQUIPMENT "DUST EXTRACTOR MACHINE VALIDATED AND RELEASED FOR

USE.

Approval:
Area Representative

Production
Engineering Services
Quality Engineering
Quality Assurance

Signature

Date

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VALIDATION PROTOCOL FOR
DUST EXTRACTOR MACHINE

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15.0 On going Activities

15.1 Preventive Maintenance Schedule:
Sr.
No.

Preventive maintenance
details

Any major
change

Performed by

Remarks

15.2 Change in the History card:

New equipment installed on: Date Sr. Change
No recommended
by

Reason for
change

Modification Details

15.3 Modification with recommendation for re qualification:

Re-qualification Remark

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VALIDATION PROTOCOL FOR
DUST EXTRACTOR MACHINE

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16.0 Final Conclusion and Recommendation:

Approval:
Area Representative

Production
Engineering Services
Quality Engineering
Quality Assurance

Signature

Date